Lonza PyroTec PRO Instructions for use

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PyroTec™ PRO HardwareUser’s Manual, V1.2 1
RT-MN024-1.2 02/21
Hardware User’s Manual

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PyroTec™ PRO HardwareUser’s Manual, V1.2 2
RT-MN024-1.2 02/21
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0 Preface
For Your
Safety
Before performing any work on or with PyroTec™ PRO, first read this User’s Manual care-
fully, in particularchapter 2 “Safety.”
0.1 Manufacturer
Address of
Manufacturer
Lonza Walkersville
8830 Biggs Ford Road
Walkersville, MD 29414
USA
0.2 Use of the Product
0.2.1 Intended Use
Intended Use
PyroTec™ PRO is an open automation platform product forgeneral laboratory use. It is in-
tended for routine laboratory tasks, such as general-purpose pipetting, general-purpose
liquid handling, and robotic processes.
0.2.2 Improper Use
Improper Use
PyroTec™ PRO mustnot be used with options or components thatare not approved by
Lonza.
WARNING
The use of non-approved options may impair the safety concept of the PyroTec™ PRO.
This means that the safety and compliance to national and international standards, as re-
quired forUL/CSA certification, by EC directives, etc. cannot be ensured any more.
0.3 CE Conformity
Declaration of
Conformity
PyroTec™ PRO is designed and built in compliance with the basicsafety and health re-
quirements of applicable EC Directives. With the declaration of conformity, the manufac-
turer declares conformity with the provisions of the Directives.
CE Label
The CE label is affixed to the PyroTec™ PRO.
0.4 CSA Certification
PyroTec™ PRO is tested and certified by the Canadian Standards Association (CSA).
CSA Marking
The CSA marking is affixed to the PyroTec™ PRO.

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Radio
Interference
According to the ICES-001 notice the following statement applies to the PyroTec™ PRO:
English
Canadian Radio Interference Regulations
ICES-001 Notice for Industrial, Scientificand Medical Radio Frequency Generators:
This ISM apparatus meets all requirements of the Canadian interference-causing equip-
ment regulations.
Please note that this requirement is only for generators that operate at over 10,000 Hz.
Français
Réglementation canadienne en matière de perturbations radioélectriques
Avis de l'ICES-001, générateurs de radiofréquences dans le domaine industriel, scientifique
et médical:Cet appareil ISM(industriel, scientifique et médical) satisfait à toutes les exi-
gences définies parla réglementation canadienne en matière d'équipements générant des
perturbations radioélectriques. Veuillez noter qu'il s'agit d'une exigenceconcernant uni-
quement les générateurs fonctionnant au-delà de 10 000 Hz.
0.5 FCC Rules
Radio
Interference
According to the rules of the US government agency “Federal Communications Commis-
sion (FCC)” the following statement applies to the PyroTec™ PRO:
This equipment has been tested and found to comply with the limits fora Class A digital
device, pursuant to part 18 (ISMequipment) of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference when the equipment is oper-
ated in a commercial environment. This equipment generates, uses, and can radiate radio
frequency energy and, if not installed and used in accordance with the Operating Manual,
may cause harmful interference to radio communications. Operation of this equipment in
a residential area is likely to cause harmful interference in which case the user will be re-
quired to correct the interference at his own expense.
ATTENTION
Changes or modifications not expressly approved by the manufacturer could void the
user’s authority to operate the equipment.

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Table of Contents
0Preface .................................................................................... 2
0.1 Manufacturer................................................................................................2
0.2 Use of the Product........................................................................................2
0.2.1 Intended Use......................................................................................2
0.2.2 Improper Use .....................................................................................2
0.3 CE Conformity ..............................................................................................2
0.4 CSA Certification ..........................................................................................2
0.5 FCC Rules ...................................................................................................3
1About this Manual........................................................................ 9
1.1 Reference Documents ................................................................................10
1.2 Trademarks................................................................................................10
1.3 Abbreviations .............................................................................................11
2Safety .................................................................................... 12
2.1 Warning Notices Used in This Manual..........................................................12
2.2 Product Safety............................................................................................13
2.2.1 Instrument-Related Hazards and Safety Measures .............................14
3Operating Company.................................................................... 17
3.1 User Qualification .......................................................................................17
3.1.1 Operator ..........................................................................................17
3.2 Safety Elements .........................................................................................18
3.2.1 Safety Panels...................................................................................18
3.2.2 Door Locks.......................................................................................18
3.2.3 Modifications on the Safety Panels ....................................................18
3.2.4 Which are Safety Elements? .............................................................18
3.3 General......................................................................................................20
3.3.1 Product Safety Signs ........................................................................21
3.3.2 Laser Radiation ................................................................................22
3.4 Decontamination Declaration.......................................................................22
3.5General Safety Rules ..................................................................................23
4Technical Data .......................................................................... 24
4.1 Introduction ................................................................................................24

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4.1.1 PyroTec™ PRO Overview.................................................................24
4.1.2 Product Identification and Labelling ...................................................25
4.2 Configuration Data......................................................................................28
4.2.1 Air LiHa Configuration.......................................................................28
4.2.2 Tecan®Sunrise™ Reader and Loading ID .........................................29
4.3 Requirements.............................................................................................29
4.3.1 Computer Requirements ...................................................................29
4.3.2 Software Requirements.....................................................................29
4.4 System Modules .........................................................................................30
4.4.1 Air Displacement Pipetting Arm (Air LiHa) ..........................................30
4.4.2 Robotic Manipulator Arm (RoMa).......................................................34
4.5 Chemical Resistance ..................................................................................35
4.5.1 Resistance of Special Materials .........................................................36
5Description of Function ................................................................ 37
5.1 Introduction ................................................................................................37
5.2 Structure ....................................................................................................37
5.2.1 The PyroTec™ PRO Worktable.........................................................37
5.3 Function.....................................................................................................38
5.3.1 Air Displacement Pipetting Arm (Air LiHa) ..........................................38
5.3.2 Air LiHa MultiSense Functions...........................................................41
5.3.3 Robotic Manipulator Arm Standard (RoMa Standard)..........................42
5.3.4 Safety Elements ...............................................................................43
5.4 Reader.......................................................................................................44
5.4.1 Capacitive Liquid Level Detection ......................................................44
5.4.2 Clot Detection ..................................................................................45
5.4.3 Lower DiTi Eject Option ....................................................................47
5.4.4 Carriers and Racks...........................................................................47
6Installation .............................................................................. 48
6.1 Site and System Preparation .......................................................................48
6.1.1 Site Requirements ............................................................................48
6.2 Unpacking..................................................................................................50
6.3 Installing and Connecting ............................................................................51

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Note: Unless otherwise specified a contracted field specialist will perform this
procedure...................................................................................................51
6.3.1 PyroTec™ PRO Instrument...............................................................51
6.4 Checking the CAN Bus Resistance ..............................................................51
6.5 Installing Options ........................................................................................53
6.5.1 Modifications on Safety Panels..........................................................53
6.5.2 Mains Outlets for Options..................................................................54
6.5.3 Reader ............................................................................................54
6.6 Site Acceptance..........................................................................................55
7Transport, Storage and Packaging..................................................... 55
7.1 Transport ...................................................................................................55
7.2 Storage......................................................................................................56
7.3 Packaging ..................................................................................................56
8Operation ............................................................................... 63
8.1 Operating and Display Elements..................................................................63
8.1.1 Operating Elements..........................................................................63
8.1.2 Display Elements..............................................................................64
8.2 Operating Modes ........................................................................................65
8.3 Operating in Routine Operation Mode ..........................................................66
8.3.1 Safety Instructions ............................................................................66
8.3.2 Enclosed Work Area.........................................................................68
8.3.3 Switching the Instrument On .............................................................68
8.3.4 Instrument Preparation and Checks...................................................70
8.3.5 Runtime Controller............................................................................74
8.3.6 Checks and Terminating Tasks .........................................................75
8.3.7 Switching the Instrument Off .............................................................75
8.3.8 When a Crash Occurred ...................................................................75
8.4 Operating in Process Definition Mode ..........................................................76
8.4.1 Process Validation............................................................................76
8.4.2 Liquid Handling ................................................................................76
8.4.3 Maintenance ....................................................................................80
9Preventive Maintenance and Repairs................................................. 81
9.1 Tools and Consumables..............................................................................81

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9.1.1 Cleaning Agents...............................................................................81
9.1.2 For Air LiHa Maintenance..................................................................83
9.2 Maintenance Schedule................................................................................83
9.2.1 Maintenance: Immediate Maintenance...............................................84
9.2.2 Maintenance Table: Daily Maintenance..............................................85
9.2.3 Maintenance Table: Weekly Maintenance ..........................................85
9.2.4 Maintenance Table: Yearly Maintenance............................................86
9.2.5 Maintenance Table: Two-Yearly Maintenance ....................................87
9.3 Maintenance Tasks.....................................................................................87
9.3.1 Disposable Tip (DiTi) of Air LiHa........................................................87
9.3.2 DiTi Waste Bag ................................................................................92
9.3.3 DiTi Waste Station Unit.....................................................................94
9.3.4 Worktable ........................................................................................96
9.3.5 Safety Panels...................................................................................97
9.3.6 Lower DiTi Eject Option ....................................................................97
9.3.7 Arm Guide .......................................................................................97
9.4 Precision and Function Tests.......................................................................98
9.4.1 Liquid Handling Performance Verification Testing ...............................98
9.5 Decontamination.........................................................................................99
9.6 Adjustments and Replacements...................................................................99
9.6.1 Positioning Pins................................................................................99
10 Troubleshooting .......................................................................101
10.1 Troubleshooting Table ..............................................................................101
10.2 Troubleshooting Instructions......................................................................105
10.2.1 Releasing the Z-brake of the Air LiHa............................................... 105
10.2.2 RoMa / Gripper Alignment...............................................................106
11 Shutdown, Transport and Storage ...................................................107
11.1 Shutdown................................................................................................. 107
11.1.1 Instrument......................................................................................107
11.1.2 Reporting.......................................................................................108
11.2 Transport ................................................................................................. 108
11.2.1 Unpacking......................................................................................109

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11.2.2 Packaging......................................................................................109
11.3 Storage....................................................................................................109
12 Disposal.................................................................................110
12.1 Disposal of Packing Material...................................................................... 110
12.2 Disposal of Operating Material................................................................... 110
12.3 Disposal of the PyroTec™ PRO................................................................. 110
12.3.1 General Instructions........................................................................ 110
12.3.2 Local Requirements European Union............................................... 111
12.3.3 Local Requirements People’s Republic of China............................... 111
13 Spare Parts and Accessories..........................................................112
13.1 Software ..................................................................................................112
13.2 Documentation ......................................................................................... 112
13.3 PyroTec™ PRO Basic Accessories Kit....................................................... 112
13.4 Tools, Gauges .......................................................................................... 114
13.5 Optional System Modules and Accessories ................................................ 115
13.5.1 Air Displacement Pipetting Arm (Air LiHa) ........................................ 115
13.5.2 Robotic Manipulator Arm (RoMa)..................................................... 115
13.6 Carriers, Racks, Troughs........................................................................... 115
13.6.1 Carriers for Reagents and Troughs .................................................. 115
13.6.2 Carrier for Disposable Tips.............................................................. 115
13.6.3 Carriers for Tubes........................................................................... 117
13.7 Tips 117
14 Support .................................................................................118
14.1 Contacts .................................................................................................. 118

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1 About this Manual
Purpose of
This Chapter
This chapter describes the purpose of the manual, specifies the product the manual deals
with and whom the manual is intended. It explains the symbols, conventions and abbrevi-
ations used and offers othergeneral information.
Purpose of
This Manual
This manual describes the PyroTec™ PROand provides all information required for the
safe operation and maintenance of the instrument.
Product Pic-
tures
The delivered instrument may not exactly match the product pictures shown in this oper-
ating manual.
Target Group
This manual is intended for everyone who wants to learn about the safe operation and
maintenance of the PyroTec™ PRO. Laboratory personnel and operators are specifically
addressed.
Laboratory personnel operating PyroTec™ PRO instruments require thorough knowledge
of applications, instrument functions and software programs as well as all applicable
safety rules and regulations.
Scope
This manual is applicable for:
1. PyroTec™ PRO - Part No. 25-A10; 1 Plate instrument without loading ID
2. PyroTec™ PRO - Part No. 25-A20; 2 Plate instrument without loading ID
3. PyroTec™ PRO - Part No. 25-A11; 1 Plate instrumentwith loadingID
4. PyroTec™ PRO - Part No. 25-A21; 2 Plate instrumentwith loadingID

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1.1 Reference Documents
Additional reference documents are listed belowbut are not enclosed or linked.
What Does the
Doc. ID Tell
You?
The Doc. IDs listed below are rootnumbers. Therefore, they do not contain information
aboutthe language, document version orthe medium (datastorage medium, hardcopy,
downloadable file, etc.) of the document.
Check the scope of the corresponding document to make sure that you are in possession
of the correct version.
Manuals
supplied with
PyroTec™ PRO
Instruments
The following manuals are included in the shipment and considered part of a PyroTec™
PRO instrument:
•PyroTec™ PRO User Manual
Application
Software Man-
uals
According to your order configuration and the applications you plan torun, the following
documents are supplied:
WinKQCL™ Endotoxin Detection and Analysis Software User Guide Manual PyroTec™ PRO
Software User Guide
1.2 Trademarks
The following product names and any registered and unregistered trademarks
mentioned in this manual are used for identification purposes only and remain the
exclusive property of their respective owners (for simplicity reasons, the symbols
for trademarks, such as ®and ™ are not repeated later in the manual):
•WinKQCL™ and PyroTec™ PRO are trademark of Lonza Walkersville in major countries
•Tecan® Freedom EVOware®and Freedom EVO®are registered trademarks and Sun-
rise™ is a trademark of Tecan Group Ltd. in major countries